Director, Study Operations
and ensure accurate data collection in Veeva and other systems. Drive process improvements and foster interdepartmental...
and ensure accurate data collection in Veeva and other systems. Drive process improvements and foster interdepartmental...
monitoring and sampling, assays, specification setting), Supply Chain and Warehouse Management, Validation, and Quality Systems... with pharmaceutical manufacturing processes, including equipment, utilities, and facilities, cGMP compliance, high purity water systems...
developing integrations with Veeva, Documentum, Calyx/Ennov RIM, Integra’s, and Lorenz systems. Knowledge of global regulatory... and the Veeva RIM platform. The role encompasses end-to-end development, configuration, and maintenance of integrations...
within targeted institutions and systems Develops a deep understanding of the institutional customer, account & market dynamics... to leverage existing institutional relationships Proven ability to navigate hospital institutions and systems and engage...
and participate in CSV lifecycle activities for GxP systems (e.g., SAP, TrackWise, Veeva, etc.) including risk assessments, validation... computerized systems and US product distribution, including batch release, labeling, artwork approvals, and related quality system...
reporting in Veeva CRM, and other assignments by established deadlines). Provide input and instruction to all functions... systems. Achieve and maintain a satisfactory driving record rating in compliance with the Company's Motor Vehicle Driving...
, deviations, in-process data, EM data, QC release and stability testing and other quality systems documentation... of executed batch and/or critical systems documentation including certificate of analysis / certificate of conformance...
). Proficiency in Microsoft Office Suite and documentation systems such as Veeva or MasterControl. Strong analytical and problem... systems. Define process-relevant calibration requirements and ensure equipment remains fit for intended use. Support...
Strong experience with electronic document management systems (QDoccs, Trackwise, Veeva) Experience authoring and enforcing Agreements...
-functional teams, and ensuring quality systems are effective, compliant, and continuously improving. The position requires... and internal quality standards Utilize electronic document management and quality systems to manage investigations, CAPAs...